A stent holder for mounting and electrically charging a stent during coating of the stent using dry particles, the particles comprising inert polymers, pharmaceutical or biological agents, is provided. An assembly for supporting and electrically charging a stent during the coating of the stent using dry particles, the particles comprising inert polymers, pharmaceutical or biological agents, is provided. A chamber for creating an electrical field around a stent and for supporting, electrically charging, and exposing the stent to dry particles, the particles comprising inert polymers, pharmaceutical or biological agents, is provided. A method for creating an electrical field around a stent and for supporting, electrically charging, and exposing the stent to dry particles comprising inert polymers, pharmaceutical or biological agents is provided.
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1. A stent holder for removeably holding a stent during a coating process wherein the stent holder comprises
a stent mounting portion comprising at least two arms upon which the stent is mounted, the at least two arms defining a hollow space therebetween, and
an electrically chargeable section separate from the stent mounting portion,
wherein the arms form an elliptical portion configured to exert force on an inner surface of the stent,
wherein the arms are coupled to the electrically chargeable section that electrically charges the stent during the coating process and at least a portion of the electrically chargeable section includes a dimension larger than an inner diameter of the stent so that the stent sits on the electrically chargeable section, and
wherein when the elliptical portion exerts force on the inner surface of the stent, the arms diverge from a central axis of the stent holder, making at least one bend, and converge at the central axis of the stent holder, or the arms diverge from a central axis of the stent holder and arc to converge at the central axis of the stent holder, the arms touching one another both where the arms diverge and where the arms converge.
2. The stent holder of
4. The stent holder of
5. The stent holder of
6. The stent holder of
7. The stent holder of
8. The stent holder of
9. The stent holder of
10. The stent holder of
11. The stent holder of
13. The holder of
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This application claims the benefit of U.S. Provisional Application No. 60/862,592, filed Oct. 23, 2006, which application is incorporated herein by reference.
It is often beneficial to provide coatings onto substrates, such that the surfaces of such substrates have desired properties or effects.
For example, it is useful to coat biomedical implants to provide for the localized delivery of pharmaceutical or biological agents to target specific locations within the body, for therapeutic or prophylactic benefit. One area of particular interest is drug eluting stents (DES) that has recently been reviewed by Ong and Serruys in Nat. Clin. Pract. Cardiovasc. Med., (December 2005), Vol 2, No 12, 647. Typically such pharmaceutical or biological agents are co-deposited with a polymer. Such localized delivery of these agents avoids the problems of systemic administration, which may be accompanied by unwanted effects on other parts of the body, or because administration to the afflicted body part requires a high concentration of pharmaceutical or biological agent that may not be achievable by systemic administration. The coating may provide for controlled release, including long-term or sustained release, of a pharmaceutical or biological agent. Additionally, biomedical implants may be coated with materials to provide beneficial surface properties, such as enhanced biocompatibility or lubriciousness.
Conventional solvent-based spray coating processes are hampered by inefficiencies related to collection of the coating constituents onto the substrate and the consistency of the final coating. As the size of the substrate decreases, and as the mechanical complexity increases, it grows increasingly difficult to uniformly coat all surfaces of a substrate.
A cost-effective method for depositing inert polymers and pharmaceutical or biological agents onto a substrate, where the collection process is efficient, the coating produced is conformal, substantially defect-free and uniform, the composition of the coating can be regulated and the morphology and/or secondary structure of the pharmaceutical or biological agents can be controlled is described in PCT/US 06/027,321, incorporated herein by reference in its entirety. The method permits structural and morphological preservation of the agents deposited during the coating process. The method as described in PCT/U.S. 06/027,321 contemplates electrically charging the stent and creating an electrical field around the stent and stent holder during the coating method.
What is needed, therefore, is a stent holder which mounts and electrically charges a stent.
The present invention relates to a holder for mounting and electrically charging a stent during a coating process, an assembly for coupling, supporting, and electrically charging the stent holder, a chamber for controlling the electrical field around the stent and providing a platform for coating a stent, and a method of coating a stent using the electrically charged holder, electrically charged assembly, and chamber.
In one aspect, the invention provides a stent holder for removably holding a stent during a coating process wherein the stent holder charges the stent during the coating process. In one embodiment the holder forms an electrical field around the stent. In another embodiment the holder comprises a mask for masking at least a part of the stent. In another embodiment the holder comprising a support interfacing portion for interfacing with a support, wherein the support supports and electrically charges the support interfacing portion. In another embodiment, the stent holder comprises a stent mounting portion that electrically charges the stent. In another embodiment the stent mounting portion the stent mounting portion has a configuration whereby the stent slides over an elliptical portion of the stent holder. In another embodiment the stent mounting portion has a collapsed and an expanded state for minimizing coating damage during mounting or removal of the stent. In another embodiment the stent sits on an electrically chargeable section of the stent mounting portion. In another embodiment the stent mounting portion comprises a spring section. In another embodiment, the stent mounting portion comprises threads winding around a central axis. In another embodiment the threads are non-conductive. In another embodiment the threads are electrically chargeable. In another embodiment the holder further comprises a member for manipulating the electrical field around the stent. In other embodiments, the holder is in varied configurations capable of mounting and electrically charging the stent and creating an electrical field around the stent.
In one aspect, the invention provides an assembly comprising: at least one stent holder for removably holding a stent during a coating process wherein the stent holder charges the stent during the coating process; and a support for supporting the at least one stent holder, wherein the support electrically charges the stent holder. In one embodiment, the stent holder of the assembly comprises a support interfacing portion for interfacing with the support, wherein the support supports and electrically charges the support interfacing portion. In another embodiment, the support of the assembly comprises at least one coupling portion for electrically coupling to the support interfacing portion of the stent holder. In another embodiment, the support of the assembly comprises a charging portion connected to an electrical source. In other embodiments, the coupling portion is in varied configurations capable of electrically charging and supporting the holder.
In one aspect, the invention provides a chamber for a stent coating process wherein the chamber comprises:
wherein the assembly sits on the base, wherein the first base hole provides the coating nozzle access to the chamber for coating the stent, and wherein the coating nozzle is removably fitted in the first base hole. In one embodiment, the chamber further comprises at least one grounded member connected to a ground source. In another embodiment, a grounded member is removably fitted in the first or a second base hole. In another embodiment, the chamber further comprises a purge nozzle for purging the chamber, wherein the purge nozzle is fitted in the first, the second, or a third base hole. In another embodiment, the chamber further comprises an insulating stand for insulating the base from the electrical charge of the assembly, wherein the assembly sits on the insulating stand, and the insulating stand sits on the base, and wherein the insulating stand has at least one hole aligning with the first, the second, the third, or a fourth base hole. In another embodiment, the chamber further comprises a cover that fits over the assembly and sits on the base. In another embodiment, the chamber further comprises at least one insulating grounded member outside the cover, wherein the insulating grounded member is connected to a ground source and removably sits on the base. In other embodiments, the cover is transparent, comprises an insulator material, and/or is disposable. In other embodiments, the base has non-conductive properties, and/or is a thermoformed plastic part. In another embodiment, the chamber comprises an electrical source connected to the support of the assembly. In another embodiment, the assembly of the chamber comprises a plurality of stent holders arranged in a circular configuration, and wherein the coating nozzle is positioned within the circular configuration formed by the holders.
In one aspect, the invention provides a method of coating a plurality of stents wherein the method comprises:
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments and the accompanying drawings of which:
The present invention is explained in greater detail below. This description is not intended to be a detailed catalog of all the different ways in which the invention may be implemented, or all the features that may be added to the instant invention. For example, features illustrated with respect to one embodiment may be incorporated into other embodiments, and features illustrated with respect to a particular embodiment may be deleted from that embodiment. In addition, numerous variations and additions to the various embodiments suggested herein will be apparent to those skilled in the art in light of the instant disclosure, which do not depart from the instant invention. Hence, the following specification is intended to describe some particular embodiments of the invention, including the preferred embodiment, and not to exhaustively specify all permutations, combinations and variations thereof. The details of the embodiment may be changed without departing from the invention, which is defined by the claims.
Applicants specifically intend that all United States patent references cited herein be incorporated herein by reference in their entirety.
In the embodiment of
In another embodiment, the stent holder (1) has a stent mounting portion (2) in Configuration A, as shown in
In the embodiment of
In the embodiment of
The embodiment of
In another embodiment, a variation of the embodiment of
In another embodiment, a variation of
In
In the embodiment of
In the embodiment of
In the embodiment of
In the embodiment of
In another embodiment of the assembly (15), a single support (12) comprises a plurality of stent holders (1). In another embodiment, the assembly (15) comprises a support (12) having a plurality of support coupling portions (13) arranged in a circular configuration, and a plurality of stent holders (1) corresponding to the support coupling portion (13) configuration. A central hole of the support (12) provides coating equipment access to the mounted and charged stents (4). Example coating equipment comprises coating nozzles, purging nozzles, electrical field manipulation members, and grounding members.
While the description is presented in terms of the preferred embodiment, a vascular stent, the invention may be directed to any type of substrate selected from the group consisting of stents, joints, screws, rods, pins, plates, staples, shunts, clamps, clips, sutures, suture anchors, electrodes, catheters, leads, grafts, dressings, pacemakers, pacemaker housings, cardioverters, cardioverter housings, defibrillators, defibrillator housings, prostheses, ear drainage tubes, ophthalmic implants, orthopedic substrates, vertebral disks, bone substitutes, anastomotic substrates, perivascular wraps, colostomy bag attachment substrates, hemostatic barriers, vascular implants, vascular supports, tissue adhesives, tissue sealants, tissue scaffolds and intraluminal substrates. In another embodiment, the assembly comprises the substrate, wherein the substrate is mounted on a substrate holder, wherein the substrate holder electrically charges the substrate, and wherein the substrate holder is supported by a support, wherein the support electrically charges the substrate holder, the support comprising substrate holder coupling portions for electrically charging the substrate holder.
This embodiment further comprises at least one grounded member (21) connected to a ground source, wherein the at least one grounded member (21) is removably fitted in a base hole (19). The chamber (17) embodiment shown in
While the description is presented in terms of the preferred embodiment, a vascular stent, the invention may be directed to any type of substrate selected from the group consisting of stents, joints, screws, rods, pins, plates, staples, shunts, clamps, clips, sutures, suture anchors, electrodes, catheters, leads, grafts, dressings, pacemakers, pacemaker housings, cardioverters, cardioverter housings, defibrillators, defibrillator housings, prostheses, ear drainage tubes, ophthalmic implants, orthopedic substrates, vertebral disks, bone substitutes, anastomotic substrates, perivascular wraps, colostomy bag attachment substrates, hemostatic barriers, vascular implants, vascular supports, tissue adhesives, tissue sealants, tissue scaffolds and intraluminal substrates. In one embodiment, a chamber comprises:
In another embodiment, the chamber further comprises at least one grounded member connected to a ground source, wherein the at least one grounded member is removably fitted in the first or a second base hole. In another embodiment, the chamber further comprises a purge nozzle for purging the chamber, wherein the purge nozzle is fitted in the first, the second, or a third base hole. In another embodiment, the chamber further comprises an insulating stand for insulating the base from the electrical charge of the assembly, wherein the assembly sits on the insulating stand, and the insulating stand sits on the base, and wherein the insulating stand has a hole aligning with the first, the second, the third, or a fourth base hole. In another embodiment, the chamber further comprises a cover that fits over the assembly and sits on the base, and comprises an insulating grounded member outside the cover, wherein the insulating grounded member is connected to a ground source and removably sits on the base. In another embodiment, the cover is transparent, comprises an insulator material, and is disposable. In another embodiment, the base has non-conductive properties and is a thermoformed plastic part.
In another embodiment, the chamber comprises an electrical source connected to the support of the assembly.
In another embodiment of the chamber, the assembly comprises a plurality of substrate holders arranged in a circular configuration, and wherein the coating nozzle is positioned within the circular configuration formed by the holders.
In one aspect, the invention provides a method of coating a plurality of stents wherein the method comprises:
In another embodiment, the coating particles comprise inert polymers, pharmaceutical or biological agents. In another embodiment, the coating particles and exposure of the stent to the coating particles comprise the embodiments as described in PCT/U.S. 06/027,321.
While the description is presented in terms of the preferred embodiment, a vascular stent, the invention may be directed to any type of substrate selected from the group consisting of stents, joints, screws, rods, pins, plates, staples, shunts, clamps, clips, sutures, suture anchors, electrodes, catheters, leads, grafts, dressings, pacemakers, pacemaker housings, cardioverters, cardioverter housings, defibrillators, defibrillator housings, prostheses, ear drainage tubes, ophthalmic implants, orthopedic substrates, vertebral disks, bone substitutes, anastomotic substrates, perivascular wraps, colostomy bag attachment substrates, hemostatic barriers, vascular implants, vascular supports, tissue adhesives, tissue sealants, tissue scaffolds and intraluminal substrates. In one embodiment, the invention provides a method of coating a plurality of substrates wherein the method comprises:
As used in the present specification, the following words and phrases are generally intended to have the meanings as set forth below, except to the extent that the context in which they are used indicates otherwise.
“Substrate” as used herein, refers to any surface upon which it is desirable to deposit a coating comprising a polymer and a pharmaceutical or biological agent, wherein the coating process does not substantially modify the morphology of the pharmaceutical agent or the activity of the biological agent. Biomedical implants are of particular interest for the present invention; however the present invention is not intended to be restricted to this class of substrates. Those of skill in the art will appreciate alternate substrates that could benefit from the coating process described herein, such as pharmaceutical tablet cores, as part of an assay apparatus or as components in a diagnostic kit (e.g. a test strip).
“Biomedical implant” as used herein refers to any implant for insertion into the body of a human or animal subject, including but not limited to stents (e.g., vascular stents, peripheral stents), electrodes, catheters, leads, implantable pacemaker, cardioverter or defibrillator housings, joints, screws, rods, ophthalmic implants, femoral pins, bone plates, grafts, anastomotic devices, perivascular wraps, sutures, staples, shunts for hydrocephalus, dialysis grafts, colostomy bag attachment devices, ear drainage tubes, leads for pace makers and implantable cardioverters and defibrillators, vertebral disks, bone pins, suture anchors, hemostatic barriers, clamps, screws, plates, clips, vascular implants, tissue adhesives and sealants, tissue scaffolds, various types of dressings (e.g., wound dressings), bone substitutes, intraluminal devices, vascular supports, etc.
The implants may be formed from any suitable material, including but not limited to organic polymers (including stable or inert polymers and biodegradable polymers), metals, inorganic materials such as silicon, and composites thereof, including layered structures with a core of one material and one or more coatings of a different material. Substrates made of a conducting material facilitate electrostatic capture. However, the invention contemplates the use of electrostatic capture in conjunction with substrate having low conductivity or which non-conductive. To enhance electrostatic capture when a non-conductive substrate is employed, the substrate is processed while maintaining a strong electrical field in the vicinity of the substrate.
Subjects into which biomedical implants of the invention may be applied or inserted include both human subjects (including male and female subjects and infant, juvenile, adolescent, adult and geriatric subjects) as well as animal subjects (including but not limited to dog, cat, horse, monkey, etc.) for veterinary purposes.
In a preferred embodiment the biomedical implant is an expandable intraluminal vascular graft or stent (e.g., comprising a wire mesh tube) that can be expanded within a blood vessel by an angioplasty balloon associated with a catheter to dilate and expand the lumen of a blood vessel, such as described in U.S. Pat. No. 4,733,665 to Palmaz Shaz. In another embodiment the biomedical implant is a self-expanding intraluminal vascular stent (e.g., comprising a memory metal such as Ni—Ti, or Nitinol) that can be delivered with a catheter to dilate and expand the lumen of a blood vessel.
“Polymer” as used herein, refers to a series of repeating monomeric units that have been cross-linked or polymerized. Any suitable polymer can be used to carry out the present invention. It is possible that the polymers of the invention may also comprise two, three, four or more different polymers. In some embodiments of the invention only one polymer is used. In some preferred embodiments a combination of two polymers are used. Combinations of polymers can be in varying ratios, to provide coatings with differing properties. Those of skill in the art of polymer chemistry will be familiar with the different properties of polymeric compounds. Examples of polymers that may be used in the present invention include, but are not limited to polycarboxylic acids, cellulosic polymers, proteins, polypeptides, polyvinylpyrrolidone, maleic anhydride polymers, polyamides, polyvinyl alcohols, polyethylene oxides, glycosaminoglycans, polysaccharides, polyesters, polyurethanes, polystyrenes, copolymers, silicones, polyorthoesters, polyanhydrides, copolymers of vinyl monomers, polycarbonates, polyethylenes, polypropylenes, polylactic acids, polyglycolic acids, polycaprolactones, polyhydroxybutyrate valerates, polyacrylamides, polyethers, polyurethane dispersions, polyacrylates, acrylic latex dispersions, polyacrylic acid, mixtures and copolymers thereof. The polymers of the present invention may be natural or synthetic in origin, including gelatin, chitosan, dextrin, cyclodextrin, Poly(urethanes), Poly(siloxanes) or silicones, Poly(acrylates) such as poly(methyl methacrylate), poly(butyl methacrylate), and Poly(2-hydroxy ethyl methacrylate), Poly(vinyl alcohol) Poly(olefins) such as poly(ethylene), poly(isoprene), halogenated polymers such as Poly(tetrafluoroethylene)—and derivatives and copolymers such as those commonly sold as Teflon® products, Poly(vinylidine fluoride), Poly(vinyl acetate), Poly(vinyl pyrrolidone), Poly(acrylic acid), Polyacrylamide, Poly(ethylene-co-vinyl acetate), Poly(ethylene glycol), Poly(propylene glycol), Poly(methacrylic acid); etc. Suitable polymers also include absorbable and/or resorbable polymers including the following, combinations, copolymers and derivatives of the following: Polylactides (PLA), Polyglycolides (PGA), Poly(lactide-co-glycolides) (PLGA), Polyanhydrides, Polyorthoesters, Poly(N-(2-hydroxypropyl)methacrylamide), Poly(1-aspartamide), etc.
Having thus described the preferred embodiments of the present invention, those of skill in the art will be readily able to apply the teachings found herein to yet other embodiments without departing from the scope of the claims hereto attached.
Taylor, Doug, McClain, James B., Worm, Steve, Dickinson, Ed
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